Tag: Schedule M guidelines

Production under Loan Licence or Contract and Contract Analysis and Other Activities

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The pharmaceutical industry often relies on partnerships and agreements to streamline production, ensure quality, and maintain regulatory compliance. This article provides a detailed explanation of production under loan licence or contract, contract analysis, and other related activities, highlighting their importance, processes, and best practices. 1. Introduction Production under loan licence or contract and contract analysis…

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New Schedule M

Self-Inspection, Quality Audits, and Suppliers’ Audits and Approval in the Pharmaceutical Industry

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Maintaining high standards of quality and compliance is essential in the pharmaceutical industry. This article explores the concepts of self-inspection, quality audits, and suppliers’ audits and approval, providing a detailed explanation of their importance, processes, and best practices for implementation. 1. Introduction Self-inspections, quality audits, and suppliers’ audits are critical components of a robust quality…

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New Schedule M

Change Control Records

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Change control records are documents that track and manage changes made to processes, systems, equipment, or facilities in regulated industries. These records provide a systematic approach to evaluating, documenting, and implementing changes to ensure compliance, quality, and safety. Key Components of Change Control Records: Change Request: Description of the proposed change, including the reason and…

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Documentation

Deviation Reports

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Deviation reports are documents that detail any departures from established procedures, specifications, or standards during the execution of processes in regulated industries. These reports document deviations, investigate root causes, and propose corrective and preventive actions to prevent recurrence. Key Components of Deviation Reports: Deviation Description: Explanation of the deviation, including when and where it occurred….

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Product Complaint Records

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Complaint records are documents that capture information related to customer complaints, product defects, or quality issues in regulated industries. These records are used to track, investigate, and address reported concerns to ensure customer satisfaction and product quality. Key Components of Complaint Records: Complaint Details: Description of the complaint, including the nature of the issue and…

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Good Manufacturing Practices (GMP)

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Good Manufacturing Practices (GMP) are a set of guidelines and regulations that ensure pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production, from raw materials to finished products, and is crucial for ensuring the safety, efficacy, and quality of pharmaceutical products. This article provides a detailed explanation…

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New Schedule M

Quality Risk Management

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Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of pharmaceutical products. QRM is an integral part of the Pharmaceutical Quality System (PQS) and is essential for ensuring the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. This article provides a detailed…

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New Schedule M

Pharmaceutical Quality System (PQS)

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The Pharmaceutical Quality System (PQS) is a comprehensive framework that ensures the consistent production and control of pharmaceutical products in accordance with quality standards. The PQS integrates Good Manufacturing Practices (GMP) and Quality Risk Management (QRM) principles to safeguard the quality, safety, and efficacy of pharmaceutical products. This article provides a detailed explanation of the…

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New Schedule M

Product Quality Review Reports

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Product Quality Review Reports are comprehensive evaluations of pharmaceutical products conducted periodically to ensure consistency, compliance, and continuous improvement. These reports assess the quality of products, processes, and systems to identify trends, highlight areas for improvement, and maintain product quality standards. Key Components of Product Quality Review Reports: Review Scope: Overview of the products and…

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Documentation

Self-Inspection Reports

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Self-inspection reports are documents that detail the findings and outcomes of internal evaluations conducted by organizations to assess their compliance with regulations, quality standards, and best practices. These reports help identify areas for improvement, ensure adherence to guidelines, and maintain high standards of quality and safety. Key Components of Self-Inspection Reports: Scope of Inspection: Description…

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